Herbal compositions for hepatic disorders

ABSTRACT

The present invention relates to compositions comprising the herbs Salvia miltiorrhiza and Polyporus umbellatus, or extracts thereof, which are useful in treating hepatic disorders, particularly those with viral aetiology. The compositions may comprise other herbs or their extracts, and may be useful for treating hepatic disorders other than those caused by viral infection.

TECHNICAL FIELD

This invention relates to a new medicinal compositions and methods oftreating hepatic disorders.

BACKGROUND ART

Hepatic disorders, in particular those caused by viral infections, are amajor health problem and the successful treatment of hepatic diseasesposes a great challenge to the medical profession. With respect tohepatic diseases caused by viral infection, currently patients inadvanced stages of the infection cycle (chronic hepatitis) with, forexample, hepatitis C virus are treated with Interferon ("IFN") with onlyabout 25% success rate. IFN is not readily available to patients and asix-month course of IFN therapy costs about $3000. It also gives rise toseveral side-effects such as severe flu symptoms, lethargy, hair lossand undesirable tastes in the mouth. IFN acts against the virus via theimmune system and does not reverse any physiological abnormalities ordamage caused by the infection eg. hepatic cirrhosis, diminished spleenfunction, etc. Furthermore, as there is a number of hepatic disorderswhich are not caused by viral infection, the administration of INF topatients with non-viral hepatic disorders would be ineffective.

It is an object of the present invention to provide an effective methodof and medication for, treatment of both viral and non-viral hepaticdisorders which avoids or at least ameliorates one or more of thedisadvantages of current treatments.

SUMMARY OF THE INVENTION

According to a first aspect, the invention cat in a compositioncomprising the herbs Salvia miltiorrhiza and Polyporus umbellatus, orextracts thereof.

In a preferred embodiment the invention consists in a composition whichfurther comprises at least one of the herbs Curcuma longa, Astragalusmembranaceus, Loranthus parasiticus and Polygonum cuspidatum, orextracts thereof

In another preferred embodiment the invention consists in a compositionwhich further comprises at least one of the herbs Poria cocos, Artemisiacapillaris, Taraxacum mongolicum, Paeonia lactiflora, Panaxpseudoginseng, Bupleurum falcatum, Cratagus pinnatifida, Glechomalongituba, Codonopsis pilosula, Lycium barbarum, Zizyphus jujuba,Gentiana manshurica and Glycyrrhiza uralensis, or extracts thereof.

According to a second aspect the invention consists in a compositioncomprising the herbs Salvia miltiorrhiza, Polyporus umbellatus, Poriacocos, Artemisia capillaris Taraxacum mongolicum, Paeonia lactiflora,Panax pseudoginseng, Bupleurum falcatum, Crataegus pinnatifida, Curcumalonga, Glechoma longituba, Astragalus membranaceus, Codonopsis pilosula,Loranthus parasiticus, Lycium barbarum, Polygonum cuspidatum, Zizyphusjujuba, Gentiana manshurica and Glycyrrhiza uralensis, or extractsthereof.

According to a third aspect, the invention consists in a method oftreating hepatic disorders comprising the step of administering to apatient requiring such treatment any one of the compositions describedabove.

Preferably, the hepatic disorder treated is a non-viral hepatic disordersuch as alcoholic hepatitis, cirrhosis or autoimmune liver disease.

More preferably the hepatic disorder treated is caused by a viralinfection such as hepatitis virus A, B or C infection.

The treatment can be therapeutic or prophylactic, and may beadministered orally or parenterally. The parenteral route could betopical, intravenous or subcutaneous. The treatment may be delivered ina single bolus dose, multiple doses or via a slow release device or adepot.

DESCRIPTION OF THE PREFERRED EMBODIMENT

In a preferred embodiment of the invention, the composition of theinvention comprises Salvia miltiorrhiza and Polyporus umbellatus in theproportion of from 1:1 to 1:5 or 5:1. For example, these herbs may eachcomprise from 6 to 30% of the total weight of the herbal composition,the balance being made up for example by other herbs, preferably Curcumalonga (2-10%), Astragalus membranaceus (5-30%), Loranthus parasiticus(5-30%) and Polygonum cuspidatum (3-20%).

Although the administration of a composition containing only Salvia andPolyporus will be effective in treating chronic hepatitis, the synergismbetween all the herbs render the administration of a combinationcontaining each herb desirable.

Thus, in a more preferred embodiment, the composition comprises eachherb combined in the proportions given in Table 1.

Various parts of each herb may be used and these include the root, stem,fruit or whole plant or tuber.

The availability of the herbs and ease of concentrating the extractsprovides a cheaper, alternative medicine which also does not give riseto undesirable side-effects. There is also a higher incidence of cure inthat liver cirrhosis may be reversed and hepatic enzyme levels andmicrocirculation may be normalised, thus rendering this form oftreatment applicable not only to hepatic disorders caused by virusinfection but also those disorders caused by other agents and causeswhich can compromise liver function and microcirculation.

The invention will now be described with reference to the followingexample to illustrate a preferred embodiment only and does not serve tolimit the invention.

EXAMPLE 1

One method of preparing the compositions of the invention is to mix thecut, ground or powdered herbs listed in Table 1 and boil the mixture ina vat. The liquid is thus concentrated into a paste which cansubsequently be processed further into tablets averaging about 170 mgeach, using procedures which conform to standard, General ManufacturedProducts (GMP) guidelines.

                  TABLE 1                                                         ______________________________________                                        Medicinal composition comprising herbal extracts in pill-form.                Powdered Herbs      Weight                                                    ______________________________________                                        Polyporus umbellatus root                                                                         16 mg                                                     Salvia miltiorrhiza root                                                                          14 mg                                                     Artemisia capillaris Thunb.                                                                       14 mg                                                     Poria cocos root    12 mg                                                     Taraxacum mongolicum plant                                                                        12 mg                                                     Paeonia lactiflora root                                                                           10 mg                                                     Astragalus membranaceus root                                                                      10 mg                                                     Loranthus parasiticus stem                                                                        10 mg                                                     Glechoma longituba plant                                                                           9 mg                                                     Codonopsis pilosula plant                                                                          9 mg                                                     Polygonum cuspidatum root                                                                          9 mg                                                     Gentiana manshurica plant                                                                          9 mg                                                     Bupleurum falcatum root                                                                            7 mg                                                     Crataegus pinnatifida fruit                                                                        7 mg                                                     Lycium barbarum fruit                                                                              7 mg                                                     Zizyphus jujuba fruit                                                                              7 mg                                                     Curcuma longa tuber  5 mg                                                     Panax pseudoginseng root                                                                           3 mg                                                     Glycyrrhiza uralensis root                                                                         5 mg                                                     (colouring/coating)                                                           ______________________________________                                    

Consumption of 8 tablets three times daily, 30-60 minutes prior to mealswith warm water is recommended for adults. Children may be prescribedhalf the adult dosage. The dosage and the formulation may be variedaccording to the condition treated and the concentration of activeingredients used in each dose. Thus, the dosage may range from 3 to 10tablets three times daily, or more or less frequently as required. Thecompositions may also be administered as a liquid or in the form of aslow release formulation

EXAMPLE 2

An alternative method of preparing the compositions of the invention isto powder the herbs listed in Table 1 by crushing and grinding each herbafter drying it in a machine in a known, conventional manner. Theindividual components are then formulated into tablets.

EXAMPLE 3

A tablet form of the composition prepared according to Example 1 wasevaluated in patients with chronic hepatitis C (CHCV) using adouble-blind, randomised placebo controlled protocol. Treatment involved5 tablets tds for 6 months with monthly assessment by a hepatologist andtraditional Chinese medicine specialist. 58 patients were assessed, 43randomised to treatment and 40 completed therapy.

    ______________________________________                                        Results         Treated Group                                                                             Placebo Group                                     ______________________________________                                        (n) Age (yrs)   10; 40.4    20; 40.9                                          Male %          59.1        59.1                                              Duration of HCV (mths)                                                                        92          83                                                Alcohol g/d; Past interferon                                                                  20;         20;                                               Initial/final ALT                                                                             120/82      102/102                                           ______________________________________                                    

Treatment with the composition of the present invention resulted in asignificant (p<0.03) fall in ALT whereas treatment with placebo did not(Wilcoxon matched pairs signed-rank test for non-parametric date). 4patients in the treatment group normalised their ALT but relapsed oncessation of drug. Treatment had no effect on ALP, Haemoglobin, WCC andplatelets. The results of the study demonstrate that the composition wascapable of modifying disease activity in CHCV. Further studies of thetreatment on HCV-RNA and histological changes are supported by thesepreliminary results.

A person skilled in the art will understand that the therapeutic effectsof the composition result from a plurality of active agents in each herbwhich when combined, act synergistically to enhance efficacy. It willalso be understood that compositions comprising all or a selection ofsuch active agents, preferably in pure form, are also contemplatedherein, as are liquid formulations of the composition and formulationswhich are suitable for slow release administration. Thus it will beunderstood that the compositions of the invention can be administeredorally, intravenously, subcutaneously, topically or by other known means

The compositions are effective in treating hepatic disorders generally,irrespective of their aetiology since the compositions act at least inpart to improve liver function and microcirculation. The compositionsmay also exert their effect prophylactically, by preventing orminimising the adverse effects of viral infection or the action of otheragents which cause liver dysfunction. Therefore, the treatment ofhepatic disorders caused by viral infection, autoimmune reactions, drugintake and the like are contemplated herein.

The invention may be embodied in various other forms which areunderstood by those skilled in the art.

What is claimed is:
 1. A medicinal composition for treating hepatitiscomprising effective amounts of the herbs Salvia miltiorrhiza root,Polyporus umbellatus root, Poria cocos root, Artemisia capillariesThunb. plant, Taraxacum mongolicum plant, Paeonia lactiflora root, Panaxpseudoginseng root, Bupleurum falcatum root, Crataegus pinnatifidafruit, Curcuma longa tuber, Glechoma longituba plant, Astragalusmembranaceus root, Codonopsis pilosula root, Loranthus parasiticus stem,Lycium barbarum fruit, Polygonum cuspidatum root, Zizyphus jujuba fruit,Gentiana manshurica plant and Glycyrrhiza uralensis root.
 2. Acomposition of herbs according to claim 1 including approximately 14parts Salvia miltiorrhiza root, 16 parts Polyporus umbellatus root, 12parts Poria cocos root, 14 parts Artemisia capillaris Thunb. plant, 12parts Taraxacum mongolicum plant, 10 parts Paeonia lactiflora root, 3parts Panax pseudoginseng root, 7 parts Bupleurum falcatum root, 7 partsCrataegus pinnatifida fruit, 5 parts Curcuma longa tuber, 9 partsGlechoma longituba plant, 10 parts Astragalus membranaceus root, 9 partsCodonopsis pilosula root, 10 parts Loranthus parasiticus stem, 7 partsLycium barbarum fruit, 9 parts Polygonum cuspidatum root, 7 partsZizyphus jujuba fruit, 9 parts Gentiana manshurica plant and 5 partsGlycyrrhiza uralensis root.
 3. A composition according to claim 1,wherein the composition is in the form of a tablet.
 4. A compositionaccording to claim 1, wherein the composition is in the form of aliquid.
 5. A composition according to claim 1, wherein Salviamiltiorrhiza and Polyporus umbellatus each comprise from 6 to 30% of thetotal weight of the composition.
 6. A method of treating hepaticdisorders comprising the administration to a patient requiring suchtreatment a composition according to claim
 1. 7. A method of treatinghepatic disorders caused by a hepatitis C virus infection comprising theadministration to a patient requiring such treatment a compositionaccording to claim
 1. 8. A method according to claim 7, wherein thehepatic disorders result from chronic hepatitis.
 9. A method accordingto claim 7, where the composition is administered parenterally.
 10. Amethod according to claim 7, wherein the treatment is therapeutic.
 11. Amethod according to claim 7, wherein the treatment is prophylactic. 12.A method of preparing a medicinal composition for treating hepatitiscomprising the steps of:a. mixing effective amounts of the followingcut, ground or powdered herbs: Salvia miltiorrhiza root, Polyporusumbellatus root, Poria cocos root, Artemisia capillaris Thunb. plant,Taraxacum mongolicum plant, Paeonia lactiflora root, Panax pseudoginsengroot, Bupleurum falcatum root, Crataegus pinnatifia fruit, Curcuma longatuber, Glenchoma longituba plant, Astragalus membranaceus root,Codonopsis pilosula root, Loranthus parasiticus stem, Lycium barbarumfruit, Polygonum cuspidatum root, Zizyphus jujuba fruit, Gentianamanshurica plant and Glycyrrhiza uralensis root.
 13. A method accordingto claim 12, further comprising the steps of preparing said medicinalcomposition into a paste and formulating said paste into tablets.